UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059675 |
|---|---|
| Receipt number | R000068262 |
| Scientific Title | Associations among locomotive syndrome,health literacy,and physical activity in middle-aged adults(40s-50s) |
| Date of disclosure of the study information | 2025/11/07 |
| Last modified on | 2025/11/07 10:04:39 |
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Basic information
Public title
Associations among locomotive syndrome,health literacy,and physical activity in middle-aged adults(40s-50s)
Acronym
LoHLPA Study
Scientific Title
Associations among locomotive syndrome,health literacy,and physical activity in middle-aged adults(40s-50s)
Scientific Title:Acronym
LoHLPA Study
Region
| Japan |
Condition
Condition
Locomotive syndrome
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the associations among locomotive syndrome status,health literacy,and physical in adults aged 40-59 years,and to evaluate whether a one-month traning intervention can improve health literacy,physical activity levels,physical function,andlocomotive symtoms.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
The relationship between changes in health literacy and physical activity and improvements in locomotive syndrome
Key secondary outcomes
he outcomes include improvement in seven functional abilities assessed by the Locomo Check, improvement in pain and daily life difficulties assessed by the Locomo 25, establishment of regular exercise habits, and quantitative changes in body composition parameters.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
After the initial assessment,a one-month training intervention and subsequent follow-up measurements will be conducted.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
A total of 500 full-time workers aged 40-59 years will be recruted
Key exclusion criteria
Individuals who cannot provide consent to the use of their data for this study.
Individuals who are unable to complete the questionaire by themselves.
Individuals who cannot adequately understand the examiner's instructions or explanations.
Individuals whom the principal investigator deems inappropriate as study participants any ather reason.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Arakawa |
Organization
Miyazaki University
Division name
Orthopedics
Zip code
8891692
Address
Miyazaki City Kiyotakcho 5200
TEL
0985-85-1510
otmaterials@gmail.com
Public contact
Name of contact person
| 1st name | Miyuki |
| Middle name | |
| Last name | Uchimura |
Organization
Miyazaki Univercity Hospital
Division name
Unit of Rehabilitation
Zip code
8891692
Address
Miyazaki City Kiyotakcho 5200
TEL
0985-85-1510
Homepage URL
otmaterials@gmail.com
Sponsor or person
Institute
Miyazaki University
Institute
Department
Personal name
Funding Source
Organization
Self funded
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Miyazaki University
Address
Miyazaki City kiyotakecho 5200
Tel
0985-85-1510
otmaterials@gamil.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 07 | Day |
Last modified on
| 2025 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068262
